TinnitusPhase 4NCT00833950
Phase Out in Tinnitus Patients
A Phase 4 study testing Phase Out treatment in pure tone tinnitus patients in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Phase Out treatment in pure tone tinnitus patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consult ENT department UZA with tinnitus
- pure tone tinnitus or narrow band noise tinnitus
- unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
- frequency tinnitus > 1kHz
- cochlear origin tinnitus
- tinnitus duration 3 months or longer
Show all 10Show fewer
- age 18y or more
- patient being able to cooperate
- patiënt able to fill in VAS
- normal MRI pontine angle
Who cannot join
- depression: BDI > 21
- pulsatile tinnitus
- pregnancy
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Out Treatment for Tinnitus
Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.
The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.
- Conditions
- Tinnitus
- Being tested
- Phase Out treatment in pure tone tinnitus patients
- Keywords
- Tinnitus, Phase Out
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Out treatment in pure tone tinnitus patientsDevice
Phase Out treatment: 30 min 3x/w during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| narrow band noise | Experimental | Phase out in narrow band noise tinnitus patients Receives: Device: Phase Out treatment in pure tone tinnitus patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: 3x/week
Secondary outcomes (1)
Score on Tinnitus Questionnaire
Measured: week 0, week 3, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833950
- Sponsor's protocol ID
- 8/2/12
- Status last verified
- Dec 2008
- First submitted
- 30 Jan 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Out Treatment for Tinnitus
- ClinicalTrials.gov ID
- NCT00833950
- Acronym / sponsor ID
- 8/2/12
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Phase Out
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase shift treatment is a new tinnitus therapy that aims at sound cancelling via complete or partial residual inhibition. This technique is based on the theory by Choy advocating that the induction of a sound wave with a 180 degree phase shift compared to the sound experienced by the patient could result in sound cancelling, likely by negation of the cortical perception of tinnitus.
The aim is to determine the efficacy of the Phase Out treatment in pure tone and narrow band noise tinnitus patients.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| narrow band noise | Experimental | Device: Phase Out treatment in pure tone tinnitus patientsPhase out in narrow band noise tinnitus patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- consult ENT department UZA with tinnitus
- pure tone tinnitus or narrow band noise tinnitus
- unilateral tinnitus, or bilateral tinnitus if both ears pure tone or both ears narrow band noise
- frequency tinnitus > 1kHz
- cochlear origin tinnitus
Key exclusion criteria (4 listed)
- depression: BDI > 21
- pulsatile tinnitus
- pregnancy
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase Out treatment in pure tone tinnitus patientsPhase Out treatment: 30 min 3x/w during 6 weeks | Device | narrow band noise |
Primary outcome
Visual Analogue Scale
Time frame: 3x/week
1 secondary outcome
Score on Tinnitus Questionnaire
Time frame: week 0, week 3, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phase Out treatment in pure tone tinnitus patients in people with Tinnitus, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 3x/week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2009.